The present invention relates to anchoring devices and methods and, in particular, to anchors for securement in first members and which allow attachment of second members to the first members. The invention accordingly relates to devices for coupling a second member, e.g., a cylindrical or tubular member, or a fastener, to a first member.
There is a need for a simple acting and quickly installable device for coupling a second member to a first member. There is particularly a need for such a device in the medical and surgical fields. In particular, there is a need for such a device that can be used to connect tissues or bones to other tissues or bones. Furthermore, there is a need for a device which will allow manmade materials to be connected to tissue or bones, in particular, to allow cylindrical or rod shaped objects, e.g., prostheses, to be fastened to a bore in a bone or other tissue. There is furthermore a need for an easily installable device for anchoring or fastening sutures to tissue, which sutures may then be connected to another object, for example, other tissue.
In the medical and surgical fields, there is a particular need for a device that can be coupled to a first object that is then inserted into a second object, thereby to quickly lock the first and second objects together. For example, there is a need for such a device that can connect prostheses to bone, or bone to bone. There is furthermore a need for such a connection device that is essentially hollow in the interior thereby to allow placement of parts of tissue, bone or manmade materials inside the device, such as rods, pins, sutures, valves, adhesives, flowable polymers, gels, etc.
There is also a need for a device that can lock two objects together in a quick and simple manner, for example, by compression, thereby to lock a component inside the device and simultaneously to a medium, for example, bone. There is a need for such a device for locking two components together, for example, bone and bone or tissue and bone or tissue and tissue, and which device can be left hollow to allow fluid to pass through the inserted device. There is furthermore a need for such a device that can direct or inhibit the flow of fluid passing through the device. Such a device could be used in the medical field to connect bone to bone, for example, to repair fractures or in spinal surgery. Such a device could also be used to connect other materials to bone, for example, prostheses to bone. These could be used in hip prostheses, knee prostheses or as bone plugs and dental implants.
There is furthermore a need for such a connection device that allows connection of tissue to bone. This could be used for ligament repair, meniscus repair and soft tissue repair. There is also a need for such a device that can provide tissue to tissue connections, for example, liver, lung and spleen resections.
There is also a need for such a device that allows materials to be connected to tissue, or tissue to tissue. Such a device could be used to repair tears in soft tissue that may not have avulsed from bone, such as meniscal tears, or for wound closure.
Various anchoring devices and devices for securement in tissue are known. For example, in U.S. Pat. No. 5,514,137 to Coutts, an implant is fastened in a bore by applying an effective amount of resorbable cement such that temporary fixation occurs until permanent fixation occurs by osteogenic growth between the bone and part of the implant. In U.S. Pat. No. 5,192,282, to Draenert, a screw is fastened in a bore in an essentially vacuum-tight manner and a substance is delivered into bone through a longitudinal communication channel in the screw. In U.S. Pat. No. 4,712,957, to Edwards, a fastener is secured by introducing a fluent adhesive into longitudinal channels formed along the shank of the fastener. In U.S. Pat. No. 5,665,110 to Chervitz, et al., a suture is anchored into a hole created in bone by filling the hole containing a suture with an adhesive material. In U.S. Pat. No. 5,702,446 to Shenck, a prosthesis is affixed in bone by utilizing a port hole in the prosthesis to introduce fluid into an internal chamber that is connected to the porous mesh bone-mating surface. In U.S. Pat. No. 4,653,489 to Tronzo, a hip screw fixation is enhanced through the delivery of cement to a through-bore in the screw having longitudinally spaced fenestrations in one side. In U.S. Pat. No, 4,494,535 to Haas, a cannulated hip fixation nail has a plurality of ports located in flanges that are separated by fluted areas to receive a cement. In. U.S. Pat. No. 4,653,487 to Maale, a cannulated intramedullary rod has circumferentially spaced threaded apertures to allow cement to discharge into adjacent bone tissue.
In each of the above patents, a flowable material is used in conjunction with a device to provide fixation or to enhance fixation of a device in tissue.
In another patent, U.S. Pat. No. 5,643,319 to Green, a surgical instrument is used to apply a fastener with two legs joined by a flexible material. This instrument and fastener system does not use a flowable material.
None of these patents, however, provides for a convenient means to quickly and securely anchor at least one member in at least one medium by using a single tool to deliver both the member and the flowable, curable material.
It is an object of the present invention to provide an anchoring device for securement in a medium.
It is also an object of the present invention to provide a connection device for connecting a first object to a second object and, particularly such a connection device that is simple to use and quick acting.
It is yet a further object of the present invention to provide such a connection device that is suitable for the medical and surgical fields.
It is yet still a further object of the present invention to provide such a device that is suitable for use with bone, tissue or foreign objects, for example, prosthetic devices or any combinations thereof.
The above and other objects of the present invention are achieved by an installation tool, for the placement of both a member and a flowable material into a medium. The tool comprises a hollow distal longitudinal section with at least a portion in contact with at least a portion of the member. The longitudinal distal section of the tool is capable of both controlling the member and delivering the flowable material into the medium. The distal longitudinal section of the tool is connected to a proximal handle that serves for inserting the member and injecting the flowable material into the medium.
The objects of the present invention are also achieved by a method for using an installation tool for the placement of both a member and a flowable material into a medium. The method comprises using an installation tool with a hollow distal longitudinal section with at least a portion in contact with at least a portion of the member. The longitudinal distal section of the tool is capable of both controlling the member and delivering the flowable material into the medium. The distal longitudinal section of the tool is connected to a proximal handle that serves for both inserting the member and injecting a flowable material into the medium.
Another object of the present invention is to provide an installation tool that can insert a member by applying rotational force, such as for example, a threaded member, and deliver a flowable material into a medium.
Yet another object of the present invention is to provide an installation tool that can insert a member by applying an axial force, such as for example, a wire, anchor, staple, rod, tube, suture, etc., and deliver a flowable material into a medium.
Still a further object of the present invention is to provide an installation tool that can insert a member by applying an impacting force, such as for example, a tack, nail, pin, etc., and deliver a flowable material into a medium.
Another object of the present invention is to provide an installation tool that can insert a member and deliver a flowable material in a bore in a medium.
Another object of the present invention is to provide an installation tool that can insert and maintain the position of a member in a medium while the distal most section of the tool is being withdrawn, for example, to deliver the flowable material in a distal to proximal direction.
Yet another object of the present invention is to provide an installation tool that can deliver the flowable material and then insert a member in a medium.
An additional object of the present invention is to provide a member that may be cannulated at least partially to receive either the distal section of the tool or the flowable material, or both. Furthermore, the member may have at least one side channel or port connected to the through-bore to allow the flowable material to engage with the surrounding medium.
Yet another object of the present invention is to provide a member that may have fluted sides to allow the flowable material to engage with the medium.
A further object of the present invention is to provide a member that may be a flexible element, such as a suture, at least a portion of which the flowable material may surround.
Still another object of the present invention is to provide a member that may have more than one component, at least one of which may be a flexible element, such as a staple with a suture bridge.
It is yet still a further object of the present invention to provide a fixation method and apparatus using a flowable material that is resorbable, remodelable, or permanent.
Another object of the present invention is to provide a fixation method and apparatus employing a flowable material whose curing may be reversed to allow for its removal.
A further object of the present invention is to provide a fixation method and apparatus employing a flowable material that cures in an appropriate time period for a particular application, e.g., a short time for certain sports medicine applications, and a longer time for general orthopaedic applications.
Still a further object of the present invention is to provide a fixation method and apparatus employing a flowable material that cures, hardens, becomes a solid or gel, adheres, crosslinks, polymerizes, or otherwise no longer flows.
Still another object of the present invention is to provide a fixation method and apparatus employing a flowable material that can be injected, sprayed, poured, or otherwise delivered through a cannulated section of an installation tool.
It is still a further object of the present invention to provide a method to use an installation tool to insert a member and deliver a flowable material in a medium for orthopaedic applications.
It is also an object of the present invention to provide a method to use an installation tool to insert a member and deliver a flowable material in a medium for any surgery applications in general, such as soft tissue to soft tissue apposition.
Other features and advantages of the present invention will become apparent from the following description of the invention that refers to the accompanying drawings.